Patient Information

Almotriptan Tablets, USP
(al″ moe trip′ tan)

What is the most important information I should know about almotriptan tablets?

Almotriptan tablets can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking almotriptan tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack:

• •discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• •severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• •pain or discomfort in your arms, back, neck, jaw, or stomach
• •shortness of breath with or without chest discomfort
• •breaking out in a cold sweat
• •nausea or vomiting
• •feeling lightheaded

Almotriptan tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

• •have high blood pressure
• •have high cholesterol levels
• •smoke
• •are overweight
• •have diabetes
• •have a family history of heart disease
• •are past menopause
• •are a man over 40 years old

What are almotriptan tablets?

• •Almotriptan tablets are a prescription medicine that belong to a class of medicines called Triptans. Almotriptan tablets are used:
  • oto treat acute migraine attacks in adults with a history of migraine with or without aura.
  • oto treat acute migraine headache pain in children 12 to 17 years of age with a history of migraine with or without aura, and who have migraine attacks that last 4 hours or more when not treated.
• •It is not known if almotriptan tablets are safe and effective in children 12 to 17 years of age with migraine related symptoms (nausea; light sensitivity; sound sensitivity).
• •Almotriptan tablets are not to be used to prevent migraine attacks.
• •Almotriptan tablets are not for the treatment of hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
• •It is not known if almotriptan tablets are safe and effective for the treatment of cluster headaches.
• •It is not known if almotriptan tablets are safe and effective in children under 12 years of age.

Do not take almotriptan tablets if you:

• •have or have had heart problems
• •have or have had a stroke or transient ischemic attack (TIA)
• •have or have had blood vessel problems including ischemic bowel disease
• •have uncontrolled high blood pressure
• •have hemiplegic or basilar migraine. If you are not sure if you have these types of migraines, ask your health care provider.
• •have taken any of the following medicines in the last 24 hours:
  • oergotamines
  • odihydroergotamines
  • omethysergide
  • osumatriptan
  • oeletriptan
  • ofrovatriptan
  • onaratriptan
  • orizatriptan
  • osumatriptan and naproxen
  • ozolmitriptan
• •are allergic to almotriptan malate or any of the ingredients in almotriptan tablets. See the end of this leaflet for a complete list of ingredients in almotriptan tablets.

Ask your doctor if you are not sure if your medicine is listed above.

Before you take almotriptan tablets, tell your doctor about all of your medical conditions, including if you:

• •have high blood pressure
• •have high cholesterol
• •have diabetes
• •smoke
• •are overweight
• •have heart problems or family history of heart problems or stroke
• •have kidney problems
• •have liver problems
• •are past menopause
• •are a man over 40 years old
• •are allergic to sulfa (sulfonamide)
• •are pregnant or plan to become pregnant. It is not known if almotriptan will harm your unborn baby.
• •are breastfeeding or plan to breastfeed. It is not known if almotriptan passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take almotriptan tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines called:

• •selective serotonin reuptake inhibitors (SSRIs)
• •serotonin norepinephrine reuptake inhibitors (SNRIs)

Also tell your doctor if you take certain other types of medicines used to treat fungal infection (such as ketoconazole or itraconazole) or to treat HIV/AIDS (such as ritonavir).

Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take almotriptan tablets?

• •Take almotriptan tablets exactly as your doctor tells you to take them.
• •If your headache comes back after your first dose, you may take a second dose 2 hours or more after the first dose. If your pain continues after the first dose, do not take a second dose without first checking with your doctor.
• •Do not take more than 2 almotriptan tablets in a 24-hour period.
• •If you take too many almotriptan tablets, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking almotriptan tablets?

Almotriptan tablets may cause dizziness, sleepiness, and problems seeing. Do not drive, operate machinery, or do other dangerous activities until you know how almotriptan tablets affect you.

What are the possible side effects of almotriptan tablets?

Almotriptan tablets may cause serious side effects, including:

• • See “What is the most important information I should know about almotriptan tablets?”
• • changes in color or sensation in your fingers and toes (Raynaud's syndrome)
• • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • osudden or severe stomach pain
  • ostomach pain after meals
  • oweight loss
  • onausea or vomiting
  • oconstipation or diarrhea
  • obloody diarrhea
  • ofever
• • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • ocramping and pain in your legs or hips
  • ofeeling of heaviness or tightness in your leg muscles
  • oburning or aching pain in your feet or toes while resting
  • onumbness, tingling, or weakness in your legs
• • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using almotriptan tablets, especially if almotriptan tablets are used with antidepressant medicines called SSRIs or SNRIs. Call your doctor if you have any of the following symptoms of serotonin syndrome:
  • omental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • ofast heartbeat
  • ochanges in blood pressure
  • ohigh body temperature
  • otight muscles
  • otrouble walking
  • onausea, vomiting or diarrhea
• • medication overuse headaches. Some people who use too many almotriptan tablets, for 10 or more days every month, may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with almotriptan tablets. Keep a headache diary by writing down how often you have a headache and when you take your medicine.
• • allergic reactions. Some people who are allergic to sulfa medicines may be allergic to almotriptan tablets. Stop taking almotriptan tablets and call your doctor or get emergency help right away if you get any of these symptoms of an allergic reaction:
  • oa swollen face, lips, mouth, tongue or throat
  • odifficulty swallowing or breathing
  • oan itchy rash (hives)

The most common side effects of almotriptan tablets in adults are:

• •nausea
• •dry mouth
• •tingling or burning feeling (paresthesia)

The most common side effects of almotriptan tablets in adolescents are:

• •dizziness
• •sleepiness
• •headache
• •tingling or burning feeling (paresthesia)
• •nausea
• •vomiting

These are not all the possible side effects of almotriptan tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store almotriptan tablets?

• •Store almotriptan tablets at room temperature between 20°C to 25°C (68°F to 77°F).
• •Safely throw away medicine that is out of date or no longer needed.

Keep almotriptan tablets and all medicines out of the reach of children.

General information about the safe and effective use of almotriptan tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use almotriptan tablets for a condition for which they were not prescribed. Do not give almotriptan tablets to other people, even if they have the same symptoms you have. They may harm them. You can ask your pharmacist or healthcare provider for information about almotriptan tablets that is written for health professionals.

What are the ingredients in almotriptan tablets?

Active ingredient: almotriptan malate

Inactive ingredients: hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), sodium stearyl fumarate and titanium dioxide.

Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Manufactured by: Mylan Laboratories Limited Hyderabad – 500 096, India

For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

This Patient Information has been approved by the U.S. Food and Drug Administration

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India
Code No.: MH/DRUGS/25/NKD/89

75061692